AL Amyloidosis - Market Insights, Epidemiology, and Market Forecast-2030
発行: DelveInsight Business Research LLP
ページ情報: 英文 178 Pages
当レポートでは、世界の主要7カ国 - 米国、欧州主要5ヶ国 (EU5：フランス・ドイツ・イタリア・スペイン・英国)、日本 - におけるAL (Amyloid light-chain) アミロイドーシスの疫学的動向と今後の市場見通しについて分析し、疾患の概要や市場の基本構造、現在の治療法とアンメットニーズ、有病者数の動向見通し、上市済み／治験中の治療薬のプロファイル、世界全体／各国の市場規模 (過去3年間・今後11年間分)、主な市場促進・抑制要因、といった情報を取りまとめてお届けいたします。
DelveInsight's 'AL Amyloidosis - Market Insights, Epidemiology, and Market Forecast-2030' report delivers an in-depth understanding of the AL amyloidosis, historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
The AL Amyloidosis market report provides current treatment practices, emerging drugs, and their market share of the individual therapies, current and forecasted AL amyloidosis symptoms market size from 2017 to 2030 segmented by seven major markets. The report also covers current AL amyloidosis symptoms treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Study Period: 2017-2030
Amyloidosis refers to a group of complex diseases caused by protein misfolding and aggregation into highly ordered amyloid fibrils that deposit in tissues, resulting in progressive organ damage. A cross-B-sheet quaternary structure characterizes these amyloid fibrils. It is typically found in individuals with monoclonal gammopathy.
AL amyloidosis is characterized by the proliferation of clonal plasma cells. It causes the increased production of immunoglobulin light chains to become misfolded and aggregate into amyloid fibrils, leading to organ damage. As the amyloid builds up in an organ, nerve, or tissue, it gradually causes damage and affects their function. Each amyloidosis patient has a different pattern of amyloid deposition in their body. It often affects more than one organ, except the brain.
Changes in proteins, turning them into amyloids, occur because of gene mutations in DNA within cells. As amyloids are insoluble, they deposit in organs and tissues, causing amyloidosis; these amyloid proteins accumulate mainly in the tissue space between cells. The Washington University Amyloid Center is among the few places in the US capable of treating this rare condition. Their experienced team offers leading-edge treatments to help improve the patient's symptoms.
It covers the details of conventional and current medical therapies and diagnosis available in the AL amyloidosis market for the treatment of the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.
DelveInsight's AL amyloidosis market report gives a thorough understanding of AL amyloidosis symptoms by including details such as disease definition, symptoms, causes, physiology, and diagnosis. It also provides the symptoms, treatment algorithms, and treatment guidelines for AL Amyloidosis symptoms in the US, Europe, and Japan.
Early diagnosis remains vital for improving treatment efficacy and overall survival. Earlier diagnosis and better treatment options have reduced early deaths and improved survival in the past few years. When amyloid deposits are detected in biopsy samples, accurate identification of the precursor protein is crucial to guide treatment. This is feasible using immunohistochemistry, in highly specialized laboratories, and using immune-electron microscopy. The mass spectrometry-based analysis of the amyloid-containing tissues is now considered the best approach, with a reported sensitivity of 88% and specificity of 96% higher than immunochemical techniques. Also, the mass-spectrometry-based analysis does not require a large panel of antisera to identify non-AL amyloidosis.
Treatment for AL amyloidosis is tailored to the patient with their health in mind. The type of treatment is based on disease progression and the seriousness of the patient's organ, tissue, and nerve involvement. Supportive treatment is helpful for various symptoms, including cardiac and kidney problems, and can change many people's quality of life.
The AL Amyloidosis symptoms epidemiology division provides insights about the historical and current patient pool and the forecasted trend for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
The incident cases of AL Amyloidosis in the 7MM will increase during the study period, i.e., 2017-2030.
The disease epidemiology covered in the report provides historical and forecasted AL Amyloidosis symptoms epidemiology segmented as the total incident cases of AL amyloidosis, Gender-specific cases of AL amyloidosis, and age-specific cases of AL amyloidosis. The report includes the incident scenario of AL amyloidosis symptoms in 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.
The epidemiology segment also provides the AL Amyloidosis epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The total incident cases of AL Amyloidosis associated in 7MM countries were 8,550 in 2017.
The drug chapter segment of the AL Amyloidosis report encloses the detailed analysis of AL amyloidosis early-stage (Phase-I/II, II, and III) pipeline drugs. It also helps to understand the AL Amyloidosis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
The AL amyloidosis market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted AL amyloidosis market trends by analyzing the impact of current therapies on the market, unmet needs, drivers, and barriers and demand of better technology.
This segment gives a thorough detail of AL Amyloidosis market trend of each marketed drug and early-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to DelveInsight, the AL Amyloidosis market in 7MM is expected to grow during the study period 2017-2030.
High-dose melphalan followed by ASCT is one treatment option included in the National Comprehensive Cancer Network guidelines. Induction with high-dose melphalan followed by ASCT has significantly impacted the ability to achieve a deep hematological response, organ response, and improved survival in patients eligible for this procedure. In recent years, bortezomib-based regimens were more frequently used as a pre-ASCT induction and increased survival. This treatment method is associated with significant side morbidity and mortality; therefore, only about 20-30% of patients are eligible. The PFS by period among the ASCT-treated patients was in the range of 53 months and giving survival for more than 2 years. HSCT and its associated complications are costly, depending on patient characteristics, transplant center experience, graft type, hospitalization duration, and transplantation complications. Further, hematological relapses or progression after ASCT occurs in 36-38% of patients at a median of 2.0-4.3 years after treatment.
Among the ineligible ASCT patients, the inflection point seems to have occurred around 2005, with incremental PFS or OS benefit observed in the most recent era, with the introduction of melphalan, in combination with dexamethasone (MDex) as a substitute for melphalan and prednisone (MP). This change had a profound impact on patient survival and the treatment pattern.
This section includes a glimpse of the AL amyloidosis market in 7MM. The market size of AL Amyloidosis in the seven major markets was found to be USD 887.3 Million in 2017.
This section provides the total AL Amyloidosis market size and market size by therapies in the United States.
DelveInsight estimates show that the United States accounted for the highest market size compared to EU5 and Japan.
The total AL Amyloidosis market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
The totals AL Amyloidosis market Size and market Size by therapies in Japan are also mentioned.
This section focusses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2017-2030. The analysis covers the AL amyloidosis market uptake by drugs, patient uptake by therapies, and drug sales.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size, which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.
The report provides insights into the therapeutic candidate in phase I/II, II, and III stages. It also analyses AL Amyloidosis key players involved in developing targeted therapeutics.
Major players include Janssen Pharmaceuticals, Caelum Biosciences, Oncopeptides AB, and Bristol Myers Squibb.
The report covers the detailed information of collaborations, acquisitions and mergers, licensing, and patent details for AL Amyloidosis emerging therapies.
Proactively approaching reimbursement can induce a positive impact both during the early stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
Clinical practice guidelines by NCCN, UKMF provided a list of drug therapy options for AL Amyloidosis; however, none had FDA or EMA approval. This treatment landscape of AL amyloidosis is mostly derived from multiple myeloma, and none are deemed optimal due to insufficient data. High-dose melphalan followed by autologous hematopoietic stem cell transplant (ASCT) is included in the guidelines, but it is associated with significant morbidity and mortality; therefore, only about 20% of patients are eligible. Transplantation improved life expectancy, and one of the Canadian-based studies extrapolated survival and costs of the ASCT with melphalan and prednisone group. The incremental cost-effectiveness of transplantation was 25,710 Canadian dollars per life-year gained, including follow-up costs. Compared with melphalan and prednisone, ASCT appears to be cost-effective in patients less than 65 years old.
To keep up with current market trends, we take KOLs and SME's opinion working in the AL amyloidosis domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or AL Amyloidosis market trends. This will support the clients in potential upcoming novel treatment by identifying the market's overall scenario and the unmet needs.
We perform Competitive and Market Intelligence analysis of the AL Amyloidosis Market by using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.